Novartis wins FDA breakthrough therapy for AML treatment

ZURICH – Novartis received breakthrough therapy designation from the U.S. Food and Drug Administration for an investigational treatment for newly-diagnosed FLT3-mutated acute myeloid leukemia, the Swiss drugmaker said on Friday.

Patients who received PKC412, also called midostaurin, combined with standard induction and consolidation chemotherapy experienced what Novartis called "a significant improvement in overall survival".

With the announcement, Novartis's drug discovery program keeps pace with crosstown rival Roche, which this week won FDA breakthrough therapy designation for its ocrelizumab investigational therapy for primary progressive multiple sclerosis.